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FDA 510(k) Application Details - K070504
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
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510(K) Number
K070504
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
POINTE SCIENTIFIC, INC.
5449 RESEARCH DRIVE
CANTON, MI 48188 US
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Contact
RON JAMISON
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Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
02/21/2007
Decision Date
04/11/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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